Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Frozen Shoulder

Pain, Shoulder Clinical Trial

Official title:

Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037994
• Other study ID #: 6909
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The patients will be randomly allocated into two equal groups (each 20 patients) using sealed opaque numbered envelopes: Control Group (C Group) : Patients receive continuous US suprascapular nerve block only. Gabapentin Group (G Group) : Patients receive continuous US suprascapular nerve block with oral gabapentin 300 mg once daily at bed time. Both groups compared as regard: Visual Analogue Scale Range of passive and active movements Patients satisfaction complication related to block The total dose of diclofenac sodium

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Body mass index = 18 Kg/m2 = 30Kg/m2
• ASA I, II or III.
• Cooperative patients.

Exclusion Criteria:

• local infection at site of injection.
• coagulopathy
• previous history of mental disorders or chronic drug abuse (opioids, tranquilizers)
• known hypersensitivity to any of the drugs used in the study.

Related Conditions & MeSH terms

• Bursitis
• Pain, Shoulder
• Shoulder Pain

Intervention

Procedure:
• Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine
The high frequency linear ultrasound transducer (Sonosite 6-13 MHz) in a transverse orientation will be placed over the scapular Spine. Moving the transducer cephalad the suprascapular fossa will be identified. 18 gauge touhy needle will be inserted in plane after subcutaneous local anesthesia infiltration with 1 ml lidocaine 2% Real-time imaging will be used to direct injection of 2 ml lidocaine 2% to test perineural spread of injectate after confirmation of the position of tip of needle injection of 40mg methyl prednisolone diluted in 5 ml bupivacaine 0.5% will be done through the needle to anesthetize the nerve and create space for catheter insertion. After catheter insertion another 2 ml lidocaine 2% will be injected through the catheter to confirm position perineural in the scapular notch. Lastly Catheter will be fixed via skin tunnel and secured with skin sutures and adhesive tap.

Locations

Country	Name	City	State
Egypt	Amr Shaaban Elshafei	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The total dose of diclofenac sodium	Indicator for analgesia required	6 weeks
Primary	Visual analogue scale	10cm line where zero means no pain and ten means worse imaginary pain	6 weeks
Secondary	Range of passive and active movements	by goniometer	6 weeks
Secondary	Patients satisfaction	by questionnaire with 3 degrees; Fair; Good; Excellent	6 weeks